The present invention generally relates to an atrial defibrillator and method for applying cardioverting electrical energy to the atria of a human heart in need of cardioversion. The present invention is more particularly directed to a fully automatic implantable atrial defibrillator which exhibits improved safety by reducing the potential risk of induced ventricular fibrillation which may result from the delivery of cardioverting electrical energy to the atria. More specifically, the atrial defibrillator and method of the present invention guards against applying cardioverting electrical energy to the atria under conditions believed to contribute to induced ventricle fibrillation.
Atrial fibrillation is probably the most common cardiac arrhythmia. Although it is not usually a life threatening arrhythmia, it is associated with strokes thought to be caused by blood clots forming in areas of stagnant blood flow as a result of prolonged atrial fibrillation. In addition, patients afflicted with atrial fibrillation generally experience palpitations of the heart and may even experience dizziness or even loss of consciousness.
Atrial fibrillation occurs suddenly and many times can only be corrected by a discharge of electrical energy to the heart through the skin of the patient by way of an external defibrillator of the type well known in the art. This treatment is commonly referred to as synchronized cardioversion and, as its name implies, involves applying electrical defibrillating energy to the heart in synchronism with a detected ventricular electrical activation (R wave) of the heart. The treatment is very painful and, unfortunately, most often only results in temporary relief for patients, lasting but a few weeks.
Drugs are available for reducing the incidence of atrial fibrillation. However, these drugs have many side effects and many patients are resistent to them which greatly reduces their therapeutic effect.
Implantable atrial defibrillators have been proposed to provide patients suffering from occurrences of atrial fibrillation with relief. Unfortunately, to the detriment of such patients, none of these atrial defibrillators have become a commercial reality.
Implantable atrial defibrillators proposed in the past have exhibited a number of disadvantages which probably has precluded these defibrillators from becoming a commercial reality. Two such proposed defibrillators, although represented as being implantable, were not fully automatic, requiring human interaction for cardioverting or defibrillating the heart. Both of these proposed defibrillators require the patient to recognize the symptoms of atrial fibrillation with one defibrillator requiring a visit to a physician to activate the defibrillator and the other defibrillator requiring the patient to activate the defibrillator with an external magnet.
Improved atrial defibrillators and lead systems which exhibit both automatic operation and improved safety are fully described in copending U.S. application Ser. No. 07/685,130, filed Apr. 12, 1991, in the names of John M. Adams and Clifton A. Alferness for IMPROVED ATRIAL DEFIBRILLATOR AND METHOD and Ser. No. 07/856,514, filed Mar. 24, 1992, in the names of John M. Adams, Clifton A. Alferness, and Paul E. Kreyenhagen for IMPROVED ATRIAL DEFIBRILLATOR, LEAD SYSTEMS, AND METHOD, which applications are assigned to the assignee of the present invention and incorporated herein by reference. As disclosed in the aforementioned referenced applications, synchronizing the delivery of the defibrillating or cardioverting electrical energy to the atria with a ventricular electrical activation (R wave) of the heart has been considered important to avoid cardioverting the heart during the heart's vulnerable period or T wave to thus prevent induced ventricular fibrillation. Ventricular fibrillation is a fatal arrhythmia which can be caused by electrical energy being delivered to the heart at the wrong time in the cardiac cycle, such as during the T wave of the cycle. The atrial defibrillators of the aforementioned referenced applications exhibit improved safety from inducing ventricular fibrillation by sensing ventricular activations of the heart in a manner which avoids detecting noise as ventricular electrical activations for generating reliable synchronization signals. Hence, these implantable atrial defibrillators, by providing such noise immunity in R wave detection assure reliable synchronization.
Another measure for reducing the risk of inducing ventricular fibrillation during the delivery of cardioverting electrical energy to the atria of the heart employed by the defibrillators of the aforementioned referenced applications is the reduction of the amount of the electrical energy which is passed through the ventricles during cardioversion of the atria. This is achieved by locating the cardioverting electrodes in or near the heart to provide a cardioverting energy path which confines most of the cardioverting electrical energy to the atria of the heart.
It has also been observed that during episodes of atrial fibrillation, the cardiac rate often becomes highly variable. The highly variable cardiac rate is generally characterized by repetitively alternating long and short cardiac cycles which result in dispersion of refractoriness. With such highly variable cardiac rates, there can be a dispersion of refractoriness after the long cardiac cycles. This creates an increased sensitivity to an "R on T" condition contributing to the likelihood of induced ventricular fibrillation if the atria are cardioverted in synchronism with an R wave which is closely adjacent to the preceding T wave.
The atrial defibrillator and method of the present invention greatly reduces the risk of inducing ventricular fibrillation during atrial cardioversion or defibrillation by assuring that the cardioverting electrical energy is not applied to the atria during a time of dispersion of refractoriness. As will be seen hereinafter, this is accomplished by stabilizing the heart rate through pacing the ventricles at a constant or fixed cardiac rate before the cardioverting or defibrillating electrical energy is applied to the atria of the heart. Such heart rate stabilization prevents a dispersion of refractoriness condition from occurring. Furthermore, the cardioverting electrical energy is preferably applied at a time corresponding to the fixed cardiac rate while the ventricles are also paced. This assures that the cardioverting electrical energy is applied in synchronism with depolarization of the ventricles and not during a T wave. As a result, a reduced risk of induced ventricular fibrillation is assured because the cardioverting electrical energy will not be applied to the atria during an R on T condition or during a vulnerable period of the heart.